Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source

June 5, 2008 updated by: St. Justine's Hospital

The Impact of Procalcitonin on the Management of Children Aged 1 to 36 Month Presenting With a Fever Without a Source

Serious bacterial infections are often difficult to detect in children with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 36 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T1L7
        • CHU Sainte-Justine Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 1-36 months
  • With rectal temperature >38.0 C
  • And no identified source of infection after history and physical examination

Exclusion Criteria:

  • acquired or congenital immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCT+
Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm procalcitonin result is revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him
Other: Procalcitonin dosage PCT-Q test (Brahms, Germany)
Procalcitonin result available to the attending physician
Other Names:
  • PCT-Q test (Brahms, Germany)
No Intervention: PCT-
Investigations include CBC, blood culture, urine analysis and culture and procalcitonin. In this arm, procalcitonin is not revealed to the attending physician. The decision to treat with antibiotics or to hospitalize was left to him.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Difference in prescription of antibiotics between the two groups, excluding those treated for a bacterial infection identified by the ED investigations

Secondary Outcome Measures

Outcome Measure
Difference in hospitalization rate between the two groups (excluding those hospitalized for an identified infection)
Procalcitonin sensitivity and specificity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Investigators

  • Principal Investigator: Sergio Manzano, MD, St. Justine's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2008

Last Update Submitted That Met QC Criteria

June 5, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URG73

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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